LYCOS RETRIEVER 
Viral: Patients
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Despite the availability of more than 20 antiretroviral agents, the challenges of viral resistance and toxicities underscore the need for new agents with novel mechanisms of action. Schering-Plough is committed to a broad clinical development program for vicriviroc to further evaluate its utility against HIV disease when used in combination with antiretroviral drugs. Vicriviroc has been studied to date in more than 750 patients in pharmacology or clinical trials.
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At 72 weeks, a complete viral response was sustained in 40 percent of evaluable patients in all four Ceplene treatment arms combined, and in 44 percent of patients receiving the highest dosing regimen of Ceplene (10 mg per week). These results compare favorably to the 16 percent sustained complete response at 72 weeks commonly observed for patients treated with IFN-(alpha) alone. The results are being presented today at the European Association for the Study of the Liver (EASL) conference in Prague, Czech Republic.
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In January 1997, Hemispherx announced that a new Phase II clinical trial of the effect of Ampligen on HIV viral load had begun at the University of Texas Health Science Center under the supervision of Dr. Patricia Salvato. The new Phase II trial will test the efficacy of Ampligen in HIV-positive patients with CD4 cell counts of more than 400 who are not being treated with any other medications.
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Building on the ACTG study reported above, Schering-Plough Research Institute is conducting an ongoing Phase II clinical trial of higher doses of vicriviroc in treatment-experienced HIV patients, with the goal of achieving further improvement in viral suppression. VICTOR-E1 (Vicriviroc in Combination Treatment with Optimized Antiretroviral Treatment Regimen in Experienced Subjects) is evaluating the safety and efficacy of vicriviroc (20 mg and 30 mg once daily) compared to placebo in combination with an optimized ritonavir-boosted, protease inhibitor-containing antiretroviral regimen. A total of 116 patients have been enrolled in this 48-week trial at sites throughout Europe and North and South America.
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Ampligen is an actively anti-viral compound; it has been shown to stop the replication of a virus that infects both AIDS and CFS patients, Human Herpes Virus 6 (HHV-6). In fact, when cells are grown in culture with Ampligen and HHV-6, the drug blocks the virus from even infecting the cells (Ablashi, D.V. et al.; "Ampligen Inhibits Human Herpesvirus 6 In Vitro"; in vivo 8:587, 1994).
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Those similar viral responses were not a surprise, Dr. Pockros said, because both groups received the same amount of interferon alfacon-1. But the purpose of the other agent, ribavirin, is to suppress resurgence of the virus after its levels have been reduced. Thus, ``one would expect that by the end of therapy at 48 weeks, the patients getting the combination of Infergen and ribavirin would show a higher sustained response rate,'' he said.
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